Chrysalis Intelligence · Sponsors · Sunmed, LLC

Sunmed, LLC

Grand Rapids, MI, US · 1 510(k) clearances · 18 recalls (6 Class I)

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Total clearances
1
2024-08-02 → 2024-08-02
Last 12 months
0
Product codes
1
Most recent
2024-08-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IPF Stimulator, Muscle, Powered Class II Physical Medicine 1 2024-08-02
Safety

Recalls (18)

Class I (serious)
6
Risk of injury / death
Total recalls
18
Currently ongoing
17
Most recent
2025-12-15
DateSeverityStatusRecall # ProductCodeReason
2025-12-15 Class I Ongoing Z-1117-2026 Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Versio… — Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
2025-12-15 Class I Ongoing Z-1116-2026 Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Ve… — Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
2025-12-15 Class I Ongoing Z-1115-2026 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve… — Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
2025-12-15 Class I Ongoing Z-1114-2026 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software V… — Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
2025-05-15 Class I Ongoing Z-1904-2025 Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36… — The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the i…
2025-05-01 Class I Ongoing Z-1814-2025 Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F — Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to pa…
2023-10-11 Class II Ongoing Z-0369-2024 Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resus… — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2023-10-11 Class II Ongoing Z-0368-2024 Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex A… — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2023-10-11 Class II Ongoing Z-0367-2024 Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. … — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2023-10-11 Class II Ongoing Z-0366-2024 Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: … — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2023-10-11 Class II Ongoing Z-0365-2024 Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1… — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2023-10-11 Class II Ongoing Z-0364-2024 Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1… — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2023-10-11 Class II Ongoing Z-0363-2024 Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.… — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2023-10-11 Class II Ongoing Z-0362-2024 Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: … — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2023-10-11 Class II Ongoing Z-0361-2024 Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include… — A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
2022-12-22 Class II Ongoing Z-1020-2023 AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 … — There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastr…
2022-12-22 Class II Ongoing Z-1019-2023 Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 … — There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastr…
2022-09-08 Class II Terminated Z-1779-2022 Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 — The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the pat…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2024-08-02 K233098 MYOTouch Muscle Stimulator IPF Class II Physical Medicine
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence